High-Quality USP 797 Clean Room Construction

Cleanroom Logic provides high-quality USP 797 clean room construction for many industries, including pharmaceutical, healthcare, and other industries. USP 797 clean room construction depends upon constructing a cleanroom that adheres to USP 797 standards, namely that the room is capable of containing sterile hazardous materials. Trust Cleanroom Logic to properly construct, install, and enclose this cleanroom to ensure it can properly handle and contain sterile hazardous materials.

What is a USP 797 Cleanroom?

A USP 797 cleanroom is a cleanroom that adheres to USP 797 standards set by the United States Pharmacopoeia (USP) to ensure that the environment is controlled for sterile drug compounding. This is to help ensure the minimization of introducing, generating, and retaining airborne particles that could lead to microbial contamination of the end product. A USP 797 cleanroom is also designed to maintain the proper humidity, temperature, and pressure in the compounding of sterile drugs.

How is a USP 797 Clean Room Designed?

In order to design a USP 797 clean room, there must be an ISO Class 5 primary engineering control, an ISO Class 7 positive pressure buffer area, and an ISO Class 8 positive pressure ante room on-site. A USP 797 clean room requires positive pressure to ensure sterility is maintained in the event that a barrier is breached. Positive pressure also allows for the compounding of total parenteral nutrition (TPN), eye-drops, infusion, salves, antibiotic injections, oils, syringes, and more.

Contact us to learn more about our experienced team and how they can help to build your custom cleanroom and fulfill your specific requirements.